OBJECTIVES : Real-world evidence (RWE) generation for medical products is needed for regulatory and reimbursement decision-making, market access, and to aid clinician and patient understanding of how a product fits into the choices available for treating disease. Within pharmaceutical and medical device companies, this evidence generation is often housed in multiple business units which may be siloed or placed in competition. We have noticed that frameworks utilized to plan and assess evidence for regulatory and reimbursement needs have overlaps which can be leveraged to better utilize organization-wide resources by encouraging collaboration.

METHODS : We developed an integrated framework for RWE generation through comparing and contrasting development of a value strategy for reimbursement with use of a structured benefit-risk assessment (sBRA) for regulatory decision-making.

RESULTS : Both value strategy and sBRA include clarification of the disease landscape, the specific need addressed by the product (i.e., indication), description of the value messages (i.e., benefits) for the product, and identification of data. Additionally, the value strategy can provide a structured approach to identify data gaps and prioritize data collection to address those gaps – both of which are needed for regulatory risk management documents. Meanwhile, the sBRA can provide a structure to arrive at consensus language on known risks and the benefit-risk balance. The prioritization of timing and sequence of new studies, which is part of the value strategy, can be leveraged to meet the needs of those who are addressing both regulatory and reimbursement stakeholder requirements.

CONCLUSIONS : Sharing RWE generation planning across a consolidated framework allows for the possibility of utilizing one study to meet multiple business unit needs. It also allows for alignment of messaging around RWE across a company. We recommend testing and codification of this consolidated framework within companies looking to strengthen their RWE pipeline.